The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Opus Magnum Pi Knotless Fixation Device.
| Device ID | K070227 |
| 510k Number | K070227 |
| Device Name: | OPUS MAGNUM PI KNOTLESS FIXATION DEVICE |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORP. 15285 ALTON PARKWAY SUITE 200 Irvine, CA 92618 |
| Contact | Laura N Kasperowicz |
| Correspondent | Laura N Kasperowicz ARTHROCARE CORP. 15285 ALTON PARKWAY SUITE 200 Irvine, CA 92618 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-24 |
| Decision Date | 2007-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470005691 | K070227 | 000 |
| 00817470005684 | K070227 | 000 |
| 00817470005677 | K070227 | 000 |
| 00817470005660 | K070227 | 000 |
| 00817470005653 | K070227 | 000 |
| 00817470005165 | K070227 | 000 |